Compare three bowel-cleansing methods before colonoscopy: 4-L PEG with bisacodyl and docusate, 2-L PEG with simethicone, and 2-L PEG alone.
Comparative Study Between Using a 4-L Split-dose Polyethylene Glycol and Bisacodyl + Docusate Sodium Regimen Versus a 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen Versus Conventional Method for Bowel Preparation Before Colonoscopy
This test compares three bowel-cleansing methods to see which is safest, easiest to tolerate, and cleans best for adults preparing for a colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT07328880 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial at Tanta University Hospitals enrolls adults aged 18–70 undergoing outpatient colonoscopy and assigns them to one of three bowel-preparation regimens: 4-L split-dose polyethylene glycol with bisacodyl and docusate sodium, 2-L split-dose polyethylene glycol plus oral simethicone, or 2-L split-dose polyethylene glycol alone. Participants will have history-taking, clinical examination, laboratory tests, and a colonoscopy performed 24 hours after starting the preparation. Bowel cleanliness will be rated using the Aronchick bowel preparation scale, and investigators will record adverse events and patient compliance. The trial directly compares safety, tolerability, and cleansing effectiveness across the three regimens.
Who should consider this trial
Good fit: Adults aged 18–70 scheduled for an outpatient colonoscopy who can give written informed consent are the ideal candidates.
Not a fit: Patients with renal failure, cirrhosis or ascites, congestive heart failure, bleeding disorders, seizure disorder, gastrointestinal obstruction or perforation, pregnancy or lactation, or known allergy to the preparations are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the best regimen could provide better bowel cleanliness with fewer side effects, making colonoscopies quicker and more accurate.
How similar studies have performed: Similar reduced-volume PEG regimens with adjuncts such as bisacodyl or simethicone have shown mixed but generally promising results for improving tolerability and bowel cleanliness in prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing colonoscopy as a day-care procedure for various indications (lower GI bleeding, colorectal cancer screening, altered bowel habits, etc.) * Patients of either sex aged \>18 years and \<70 years. * Patients willing to give written informed consent. Exclusion Criteria: * Presence of Renal failure, cirrhosis, ascites, CCF, bleeding disorders, seizure disorder, gastrointestinal obstruction, or perforation. * History of serious adverse events to other electrolyte-based colonic lavages. * Female patients who are pregnant or lactating or considering pregnancy. * Allergy.
Where this trial is running
Tanta, Gharbyea
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (Recruiting)
Study contacts
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.